Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)

Not Applicable

Completed

• Conditions: Severe Trauma Brain Injury (sTBI); Subarachnoid Hemorrhage, Aneurysmal; Injuries, Acute Brain
• Interventions: Dietary Supplement: Peptamen AF

• Registration Number: NCT02716532
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH).

This clinical study is an open-label, non-randomized, single-center, exploratory metabolic study.

The primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Study Start: 2016-04
• Primary Completion: 2017-05-17
• Study Completion: 2017-11-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Comatose patients (defined by an initial Glasgow Coma Scale (GCS) < 9) following sTBI or aSAH.
• Female or male, aged >18.
• Abnormal head CT-Scan (contusions, hematoma).
• Intracranial monitoring with CMD, [PbtO2] and [ICP] probes as part of standard of care.
• Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests.
• Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study

Exclusion Criteria

• Signs of brain death or expected brain death within 48h.
• Pregnancy.
• Hemodynamic instability (circulatory shock, requiring vasopressors).
• Renal or liver insufficiency .
• Chronic intestinal disease.
• Patients requiring parenteral nutrition .
• Currently participating or having participated in another clinical trial during the month preceding the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peptamen AF	Peptamen AF	over 7 days

Primary Outcome Measures

Name	Time	Method
Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support	Over 7 days

Secondary Outcome Measures

Name	Time	Method
Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients	After at least 2 consecutive days of stable enteral nutrition
Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients	Over 7 days (not necessarily at stable EN).
As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients	Over 7 days
Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care	Over 7 days
To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients	Over 7 days
Evaluation of the time to reach two days of stable nutrition in all patients	Over 7 days

Trial Locations

Locations (1)

Department of Intensive Care Medicine CHUV; 🇨🇭 Lausanne, Switzerland